LyrArc Article Gist
WSJ on how America's political establishment lied about Covid's real origins in a Lab in Wuhan, China, after some in the American scientific community ignored prudent warnings about possible accidental release, and sent the virus from the US lab to a lab in Wuhan that was not fully prepared to handle it. In reality the Biden administration erred when it did not conduct an open assessment of what had happened, because this would have earned and kept the people's trust instead of dividing the country into vaccine believers and vaccine unbelievers.  Sections of the virologist community in the US and in China that promoted such research against the advice of others in the scientific community could have accepted their error with humility. The people of Asia have made great advances in this century- some call it the Asian century- great advances in manufacturing and in science. Yet they are not so fragile, the people in the Buddha lands and the land of Gandhi are not not so fragile that they could not accept that what they had achieved was on the shoulders of what hundreds of European scientists and inventors had done over three centuries since 1700. And that there was much to learn. The Chinese people and government can look with great self-respect for what they had achieved in the last 100 years not to need the condescension of the virologist community.  In a sense this divided the US people's perceptions of China, with half of the country skeptical about the virologist community's explanations accepted by the Biden administration. This was not in any way good for China and the Chinese people. In fact one can say that by handling this with an open mind would have clearly built more trust in China-US relations, and that China- US relations reached the lowest during the end of the Biden administration point with the Balloons incident. And recovered afterwards to this point of mutual respect under a frank president with candor and respect. This vaccine blunder also created further culture wars conflicts around the US, to ones based on race, LGBTQ, and other less consequential matters than the deindustrialization and loss of America's manufacturing base and its best jobs in huge numbers under the watch of Bush and Obama administrations, and their followers in the Republican and Democratic parties. What happened is that the country was split on race, gender, immigration, and belief in Christian values. Issues such as nuclear non proliferation (Iran) presented in ways that adversely affect the US. by calling it something else. In all such issues honesty is the best policy, dealing in a straight forward manner wiht the public is the best course, for reasons that are timeless and well recognized. Failure to do so on the part of the Elites only creates distrust of official explanations by the people of America. ...

LyrArc Article Gist
The experience of J&J and Novavax in vaccine manufacturing shows the importance of vaccine manufacturing and of Quality Assurance in the production of vaccines for coronavirus. The success of Pfizer and Indian companies in vaccine manufacturing shows how important it is to think early and plan early for vaccine manufacturing technologies, personnel and quality assurance. This is also why the US effort, India's billion vaccine target in 6-12 months of planning, is a great effort in thinking ahead of every aspect of vaccines and vaccinating, planning of all details, hard work, by Pfizer, by Indian pharmaceutical companies, and by the Modi and Biden administrations. 

LyrArc Article Gist
The first results of India's new vaccine policy with vaccine supplies and vaccination drive entirely run by the federal government are now showing up. Early reports are for vaccine supplies of 135 million doses in July for advance planning, and 250 million vaccine doses in August. Ramped up manufacturing of vaccines in India with the entire pharmaceutical industry in India taking part is part of the new policy. Collaboration with US manufacturing and research partners is also part of the new policy being implemented.

LyrArc Article Gist
Serum Institute in India's vaccine developed with Oxford University is a leading one of the 6 candidates in India for coronavirus vaccine. It is expected to be ready by September. ICMR also has a vaccine that could be ready by India's Independence Day of August 15. One of the vaccines is for the elderly. Serum Institute has the advantage of being one of the leading manufacturers of vaccines in the world. India makes 60% of the world's vaccines giving it much experience in manufacturing that is needed today.

LyrArc Article Gist
Murali Krishnan of DW.com has this interview with Adar Poonavalla of Serum Institute of India the largest vaccine maker in the world that makes about 60% of all vaccines used in the world. It is beginning manufacturing of the Oxford vaccine so that the manufacturing process is ready to turn out a billion vaccine doses over a short period of 1 to 2 years. Serum's Oxford vaccine would be priced at $13 per dose for coronavirus. Serum is conducting its own trials for the vaccine. About 40 million doses would be ready by October. 

India's pioneering work in vaccine production on a large scale is one of the reasons the world can tackle the future with some confidence for the economy and the health of billions of people all over the world.

LyrArc Article Gist
Pfizer and Moderna's plans to make mRNA vaccines in Africa, Asia or Latin America may take much longer than 2022. The solution to producing an mRNA vaccine in Asia that could be mass manufactured and distributed throughout Africa, Asia and Latin America is now at hand. Gennova based in India, is partnering with Seattle startup HDT Bio to attack the problem of temperature and scalability in manufacturing for a mRNA vaccine that acts as a global solution using India's manufacturing capabilities. Dr Singh who founded Gennova, says- "We wanted to solve the problem of the scalability issue, and the temperature issue. If we can solve these problems, we are building a solution not just for India, but also a global solution." Gennova received seed funding from the Indian government. Other companies in Brazil and South Africa lack the manufacturing capabilities or financing needed that exist in India. The Indian government has achieved an initial goal of one billion vaccinated in just 6 months. The next step for India in its health infrastructure buildup is a mRNA vaccine that is an improvement over Pfizer and Moderna vaccines that can be stored easily, adapted for variants, and manufactured in large quantity as a global solution. ...

LyrArc Article Gist
In a major move president Biden backs suspending IP protection for Covid vaccines, therapeutics and tests. In fall 2020 India and South Africa submitted a resolution to WTO to suspend IP protection for Covid vaccines, therapeutics and tests, From the Indian perspective this decision comes a bit late when India has already vaccinated over 1 billion people using the Astra Zeneca Oxford vaccine. The Oxford vaccine was made available to Indian manufacturing companies to make locally in a way the could be done at low cost to meet needs of over 1 billion people in India. From the perspective of pharmaceutical companies this is giving away technology even if this was a public health emergency, as shown in this editorial from WSJ.

LyrArc Article Gist
The Oxford vaccine developed in partnership with Astra Zeneca aims to be the vaccine for the world. The partnership has said it will make 2 billion doses and will provide this without making a profit at about $3 for one dose. Serum Institute of India was the leading supplier of vaccines to the world before the pandemic. Now it is preparing to make 1 billion doses of the Oxford vaccine. Already Astra Zenca has setup agreements for manufacturing  in other countries, with about 24 manufacturing facilities in countries such as Brazil, Japan, and Australia. Arrangements are also made with Russia and Mexico. The Russian partner has capacity to make 1 billion doses of the vaccine. In May the U.S. agreed to buy 300 million doses for $1.6 billion and manufacturing facilities are already being setup in the U.S.  The U.S. and other governments are sharing the risks as Astra Zeneca is hiring other companies to build the manufacturing capacity and working with them to install the new machines and supply the vaccine ingredients. For this the U.S. has Operation Warp Speed a $10 billion vaccine initiative and its organization, including the military. ...

LyrArc Article Gist
By August India will have tackled a shortage of vaccine supplies following the government decision to approve the use of Pfizer, Moderna, Novavax vaccines from US, Sputnik from Russia, and the US allowing export of vaccine manufacturing raw materials to India.

LyrArc Article Gist
Bharat Biotech and Biological E. are two companies developing vaccines in India. Bharat Biotech has asked for emergency authorization for use of its vaccine. Other Indian companies that have asked for emergency authorization are Pfizer India and Serum Institute of India. The foreign envoys will be flown to Hyderabad to be briefed on the vaccine readiness at Bharat Biotech and Biological E. In all 30 of 100 vaccines under development are being developed in India. India is a pioneer in vaccine development and manufacturing. Because of its huge population of 1.5 billion for India and Bangladesh, India has from the early years after independence in 1947 pursued a course of developing its own R&D and manufacturing of pharmaceuticals and vaccines, so that the large population can have access to medicine at a low price.

LyrArc Article Gist
Mr. Pascal Soriot of Astra Zeneca says his company has signed agreements for production of 2 billion doses of the coronavirus vaccine being developed by Oxford University. He says manufacturing is starting now because "we want it to be as fast as possible." One of the deals is with Serum Institute of India, the other is with Bill Gates of the Bill and Melinda Gates Foundation for $750 million for CEPI and GAVI organizations which he supports. Mr. Soriot says the licensing agreement with Serum Institute is to supply one billion doses for low and middle income countries, with 400 million doses ready by end of 2020. He says Astra Zeneca is building supply chains across the world and so far has secured manufacturing capacity for 2 billion doses of the vaccine. Mr Soriot tells BBC that manufacturing vaccines on this scale is not an easy thing to do. He says that Astra Zeneca will not make a profit in production of these Oxford University developed vaccines. The U.S. has secured 300 million doses of the Oxford vaccine, and the UK 100 million doses.   ...

LyrArc Article Gist
The Oxford vaccine is shown to be effective for older adults over 70 years in age. One of the key features of the Oxford vaccine is that it is designed to be accessible in cost for not just high income countries but across all parts of the world including the countries in Asia, Africa and Latin America where some of the poorest people live. The cost will be a fraction of the cost of the Moderna and Pfizer vaccine. Results for regulatory approval are expected by Christmas. This vaccine is expected to cost about $4 a dose compared to $25 for the Pfizer or Moderna vaccines. Oxford also uses a technology for the vaccine that has already been proved effective with least side effects fr other virus such as Ebola virus. Oxford researchers took the existing vaccine technology and modified it to tackle coronavirus in a way that proves effective for this virus also. Countries such as South Korea say they will not rush into the first vaccine that is available and have not responded to requests for sale from Moderna or Pfizer. India's Serum Institute is the leading manufacturer of vaccines in the world. It is preparing for production of the Oxford vaccine. India's vaccine effort includes other vaccines developed by its research institutes. The focus of India is for a vaccine that is effective as well as meet cost so that it can be used to vaccinate over 1.3 billion people. Because India has strong already established manufacturing capabilities for vaccines and is collaborating with Oxford and Astra Zeneca for a low cost vaccine it is in a position to drive the campaign for an effective plus low cost 100% accessible vaccine for people around the world. Another aspect of the Astra Zeneca partnership with Oxford is that it has committed not to make a profit from the vaccine. This is important for Oxford researchers and its organizational goals. ...

LyrArc Article Gist
Merck shingles vaccine Zostavax as a long term revenue generating opportunity of $1 billion. Problems in manufacturing and marketing the vaccine.

LyrArc Article Gist
The Oxford vaccine is showing promising results and is expected to be authorized for use by December 2020. The vaccine being developed in partnership with Astra Zeneca PLC for marketing and Serum Institute of India for mass manufacturing is shown to be proven 90% effective in preventing infections in clinical trials. The partners say there were no serous safety events and the vaccine has proven 62% to 90% effective with an average of 70%.  This vaccine is significant because it is being developed with this partnership not seeking profits from this venture, providing it at cost and keeping the price to about $4 a dose compared to competitors Moderna and Pfizer whose vaccine is expected to be at $24 a dose. The Oxford vaccine also uses existing technology for vaccines and manufacturing is being done in India with the world's top manufacturer of vaccines. By using existing technology unlike the Pfizer and Moderna technology Oxford has taken an approach that could prove to be unique by minimizing side effects for vaccines that are being developed with such speed. By not requiring refrigeration at very low temperatures the vaccine makes itself ready for immediate and widespread uses all over the world. By use in its home country India with its large population Oxford vaccine can gain even wider acceptance because of India's long experience in pharmaceutical technology and manufacturing. Of particular interest is the study of 23,000 participants showing that the 90% effective dosage is one that only requires half a dose for the first shot. This say scientists is because the vaccine first dose prepares the body for a more powerful second dose and creates the maximum effect. This means the vaccine can be used for more doses than 2 full doses. It can be stored in a fridge making it easy to use in many countries. The full study will have 60,000 participants spread across U.S. Britain, Brazil South Africa and India. ...

LyrArc Article Gist
Jenny Strasbourg of the WSJ provides this much needed report from London about the courageous decision by AstraZeneca and Oxford University to give vaccines away at no profit to the whole world, to billions of people in Africa, Asia, and Latin America. Without this brave decision by a British company and a British University the world would be a lot poorer, more variants could have happened, making us realize the great contribution Britain has made and how indispensable it is to the planet. Add to this the effort of Indian companies including Serum Institute that provided the manufacturing facilities and capabilities for making most of the British vaccine. AstraZeneca delivered 2.3 billion doses of the vaccine globally as of mid-December, according to the company. The International Monetary Fund estimates that low and middle income countries received 3.25 billion vaccines as of Dec. 11, About half of this or 1.6 billion doses were Astra Zeneca shots. This is a bigger share than any other vaccine by far and a life saver to the world. AstraZeneca stepped up early in a true to the best ideals in Britain to meet the needs of the world-  aiming to deliver 3 billion doses in 2022 and sell them at no profit as long as the pandemic continues. As the shot does not need cold storage it is ideal for India and other Asia, Africa and Latin America. "We are all very proud throughout the company of the impact we have had," says AstrZeneca CEO Pascal Soriot. By far the biggest manufacturing was done at Serum Institute of India which supplied 1.3 billion doses of the AstraZeneca vaccine to 70 countries. Mr. Modi pushed forward the export of vaccine made in India to the world from the beginning in the same spirit of cooperation and the best ideals that Britain was living upto. Serum Institute can produce as much as 250 million doses of vaccine a month making it possible for India to tackle the vaccination population of 1.3 billion people.   None of this could have happened without Oxford University and AstraZeneca and Indian companies with Mr. Modi's active support living up to the best ideals of Britain and India for the world. "When you add up the benefits to humanity, I think you'll find the vaccine holds up pretty well in terms of the ill health it has prevented, and the deaths it has prevented," says John Bell, a senior Oxford academic who in 2020 guided the University through its vaccine-partnership talks with Astra Zeneca. Because in the real world AstraZeneca shot has held up so well it is also a choice for booster shots. ...

LyrArc Article Gist
Sanofi will use its manufacturing plant in Ridgefield, New Jersey, in the US to fill vials and finish packaging of 200 million doses of Moderna vaccine, under a new agreement. This will supply the US under Moderna's US supply of vaccine agreements that run through April 2022. This is part of industry collaboration to expand supply of global vaccines, that includes Merck and Novartis.

LyrArc Article Gist
How do you setup a vaccine business. Consider Mr. Adar Poonavalla in the city of Pune in India. His company Serum Institute of India, remains family owned. Founded in 1966 by Cyrus Poonavalla, it produces billions of doses of vaccines for measles, polio and other diseases. It is expected to be one of the key sources of vaccines because of its expertise and the stocks of vials and other supplies that it has in stock for the next 2 years of vaccine production. It is working on a separate facility for coronavirus production that could turn out 800 million doses of vaccine at a price of about $13 a dose over 2 years. Serum Institute is working with 3 companies that are doing the research on the vaccine for coronavirus in the U.S. and Europe, and will play a key role in the manufacturing of vaccines. To respond to the question how do you setup a company to produce vaccines for the people of the world. This is what Mr. Poonavalla says- he will only work with ethical long term funds and sovereign funds because he does not want to be in the situation where he has to charge high prices to give them returns. Unlike most countries in the world, India is unique in making certain that most of the basic pharmaceutical drugs are available to over a billion people at a low cost. Serum's goal is low cost quality vaccine production so that over a billion people in Asia can be "protected from the birth onwards." As the U.S. and Europe and large parts of Asia, Africa and Latin America, face the second vaccine phase of the coronavirus response following difficulties in PPE, Ventilators, and Masks in the first phase, they can have confidence because of companies such as Serum and the research centers in U.S. and Europe like the one at Oxford University. ...

LyrArc Article Gist
The Hindu data team looks at the Indian vaccination drive with graphs by state and progress by dates. During the first 10 days of June the vaccination drive has been stepped up. It is now over 3 million a day and at this rate should reach 400 million vaccinated by the end of July, 100 million below target. For the remainder of the year vaccine supplies have to be pushed up so that 8 million doses can be given each day. This would get India to where everyone in the country of 1.2 billion has been vaccinated by Dec 31, 2021. This would make it possible for India to then use its technology and large manufacturing capacity to help other nations in Asia, Africa and Latin America in 2022. This is the first time in history that India has taken on a challenge of this size and complexity. The vaccine strategy has changed to where the federal government is taking over the overall responsibility of coordinating the production of vaccines in the country and providing access to vaccines from other countries. Federal government is also taking on overall responsibility for distribution of vaccines and setting up the logistical effort. Vaccine supply is being opened up by opening India to multiple vaccines including Pfizer, Moderna, and other vaccines. Production of Covaxin is being stepped up. This strategy is designed to get India to somewhere closer to the 8 million doses a day needed and to ensure distribution and logistical efforts are in place. More resources are put into the effort. The speed of economic recovery also depends on the vaccination drive. Lessons were learned during the second wave in May 2021 and the government is better prepared for the hard work ahead. ...

LyrArc Article Gist
In a bold decision that shows courage and foresight president Biden lifts IP protection for Covid 19 vaccine patents of American companies such as Pfizer, Moderna, J&J and Novavax. This has huge implications for vaccination supplies for countries such as India, Indonesia, Brazil, Mexico, that are hard hit by the pandemic as well as the rest of the world. It will open up manufacturing additional vaccine supplies in countries as diverse as France and India, that can ramp up quickly because of already established pharmaceutical bases.

LyrArc Article Gist
US president Biden created the largest boom in manufacturing since the space race in the 1960's. It is now at risk because of failures early in 2021-2022 in the Biden administration trying to be humane in migrant policy, but in reality also because of the bigger issues of the pandemic, vaccine skepticism, the economy, the Ukraine war in Feb. 2022 that delayed action till 2023, and the unanticipated complete collapse of Venezuela's economy leading to migrant surge. The Border was closed in 2024 by president Biden. When Trump blocked passage of Republican legislation supported by Biden, senior Republicans asked Biden to block migrant entry by executive order, Biden acted and the Border was closed. Will it now reverse the biggest manufacturing boom the US has had since 1960? How much blame should Biden take when he acted forcefully on all fronts- the pandemic, vaccines, manufacturing, and on no. 4 by closing the southern Border in 2024 by executive order? ...

LyrArc Article Gist
Astra Zeneca vaccine effectiveness gets a new boost from the late stage trial results for US, Chile and Peru that has 32,000 volunteers. The study shows Astra Zeneca vaccine 100% effective to prevent hospitalization and deaths, and 79% effective to prevent symptomatic illness. The vaccine is also known as the Oxford vaccine because it was developed at labs in Oxford University, England.

The vaccine is now preparing for US FDA regulatory approval. Its worldwide use will give new hope to the world's population because it is being given at cost and can be stored in ordinary refrigerators for long periods. Conditions that give it wide access in poor countries. It is also manufactured in India by The Serum Institute, one of the largest vaccine manufacturing labs in the world, which would make it possible to make the billions of doses needed.

LyrArc Article Gist
A Phase 1 trial of over a thousand volunteers shows the Oxford vaccine works well with minimum side effects that can be handled with acetaminophen. Phase 2 trial is underway with volunteers in UK, Brazil and South Africa. Participants given the vaccine had significant increase in antibodies to neutralize the disease, and T cells for long term protection. About 70% reported fatigue or headaches which can be handled with acetaminophen. After the Ebola crisis of 2014 in West Africa the British government invested 120 million pounds to form a group to develop vaccines for top 10 likely threats dubbed "Disease X." On this list was the coronavirus. Scientists at the Jenner Institute at Oxford formed a team as part of this effort. Sarah Gilbert and Adrian Hill led the scientists at Jenner and pioneered research for  a new way to do this- to first replace a part of the virus with a component of the new virus. Then to remove the part of the virus that allows it to replicate in humans. This method is called recombinant adenovirus vector. The Oxford scientists used existing technology in new ways to increase the chances of getting a good vaccine early.  The first vaccine could be developed and tested for mass production by September. A 30,000 participant trial begins in U.S. in August. About 1 billion doses could be manufactured by end of 2020. India's Serum Institute has the manufacturing facilities to do this near Pune, India.  ...

LyrArc Article Gist
This video in The Indian Express shows how president Biden invoking US defense act provisions to ensure supplies of vaccine ingredients to US companies prevents exports to countries that badly need it. India has surpassed 300,000 daily cases of coronavirus on April 22, and India's largest vaccine manufacturer Serum Institute of India says vaccine manufacturing in India is restricted because of president Biden invoking that law. 

India's vaccination drive is stalling because of not enough vaccine supplies.

LyrArc Article Gist
The U.S. is moving quickly to gain access to an effective vaccine by September or October 2020. It is doing this by providing the money for companies to conduct trials and ramp up manufacturing in a big way. The U.S. government has agreed to give Astra Zeneca upto $1.2 billion to secure supply of a Oxford University developed vaccine which could be ready by October. Astra Zeneca has agreed to make the vaccine under a licensing deal with Oxford University's Jenner Institute and promised it will not make a profit on this. U.S. has also given $483 million to Moderna in Cambridge, Massachusetts, for making the vaccine. Both Oxford and Moderna are testing the vaccine on humans. Oxford uses a tested older technology, Moderna a new technology. UK has given Astra Zeneca $79 million to secure 100 million doses of the vaccine, with 30 million ready by September. Oxford is also in negotiations with Gavi the international vaccine alliance, and Coalition for Epidemic Preparedness Innovations on further deals to boost production. Oxford began a 1100 person study in April, and is  doing a 5000 person trial in late May.  ...

LyrArc Article Gist
As Pfizer prepares shipments of 25 million doses of vaccine in the U.S. this WSJ report looks at how Pfizer CEO Albert Bourla pushed his manufacturing managers to the limit to increase production. He wanted 100 million doses for 50 million people by the end of 2020, production would have to be ten fold what the initial targets were. Pfizer will achieve half that which is an achievement considering how much had to be done. This report looks at the development of the vaccine at Pfizer since the early days in March when the collaboration with BoNTech in Germany began.